SFDA with New Medical Device Marketing Authorization (MDMA) and Fast Track Fee

The Saudi Food and Drug Authority (SFDA) informs medical devices manufacturers and their Authorized Representatives that Marketing Authorization fess (MDMA) has been updated according to the table below:

Notes:

• New fees take into account number of products in the application regardless of devices risk classification.

• Devices accessories are counted within the number of products

• Application shall comply with SFDA criteria of Bundled devices.

SFDA is also introducing Fast track service. This new propose fees will be in place soon.

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